This invention relates to an improved vial connector assembly or transferset, a method of affixing a transferset to a vial and a method of establishing fluid communication between a vial and syringe, IV set or the like which permits the use of a conventional or standard vial and syringe or the like to transfer fluid from a syringe to a vial or withdraw liquid medicament, for example, from a vial to a syringe. The improved transferset and method of this invention results in improved aspiration or reaspiration of a vial and improved sealing of the communication between a vial and a syringe.
It is now conventional to reduce certain drugs to a dry or powdered form to increase the shelf life of drugs and reduce inventory space. Such dry or powdered drugs are generally stored in a sealed vial and reconstituted into liquid form for administration to a patient by adding a diluent or solvent. A conventional vial includes an open end, a rim surrounding the open end and a reduced diameter neck portion adjacent the rim. The vial is conventionally sealed with an elastomeric stopper which includes a portion inserted into the neck of the vial and a planar rim portion which overlies the vial rim. The stopper is normally secured to the vial rim with an aluminum collar or cap. The aluminum collar includes a tubular portion which surrounds the rim portions of the stopper and vial, an inwardly projecting annular portion which overlies the rim portion of the stopper and a distal portion which is crimped into the vial neck beneath the vial rim portion. Because aluminum is malleable, the collar accommodates the buildup of tolerances of the dimensions of the stopper and vial rim. The dimensions and tolerances of standard vials and stoppers are set by the International Standards Organization (ISO).
A powdered drug is generally reconstituted by inserting the needle of a syringe through the pierceable stopper on the vial and injecting a diluent, such as water, or a solvent into the vial. The reconstituted drug is then reaspirated from the vial with the same or a different syringe after mixing the diluent or solvent with the dry drug. As will be understood, this method exposes the healthcare worker to being pricked by the needle of the syringe and contamination of the needle or the drug.
The prior art has therefore proposed various fluid or liquid transfer assemblies which may be secured to a vial under sterile conditions and which may then utilized to transfer liquid, such as a diluent or solvent, from a syringe to a vial and reconstituted medicament from the vial to a syringe which prevent contamination of the liquid medicament. In the most preferred embodiments, the assembly is protected from contamination by a cap or cover which is removed only prior to use. In the embodiments disclosed in the prior art, the transfer assembly includes a needle which pierces the stopper of the vial and the liquid is transferred through the needle lumen as disclosed, for example, in U.S. Pat. No. 5,429,256. In other embodiments, the conventional vial stopper is eliminated in favor of a fluid transfer assembly having a rubber stopper which is inserted into the neck of the vial without a planar rim portion. The stopper remains within the vial until such time as reconstitution of the drug is required. When the transfer assembly is actuated, the stopper is urged toward the interior of the vial to open the neck, thereby permitting fluid flow through the transfer assembly into the vial body. Examples of such embodiments include the MONOVIAL(copyright) line of drug delivery devices manufactured and sold by Becton Dickinson Pharmaceutical Systems of Le Pont de Claix, France and exemplified by U.S. Pat. No. 5,358,501. Although this embodiment is an excellent drug reconstitution system having superior properties, particularly convenience of use and maintenance of the sterile conditions of the drug in the vial, particularly where the vial is of a relatively large size, typically twelve milliliters or more, pharmaceutical companies have expressed an interest in an approach where the vial may also be a smaller size.
The need therefore remains for a vial transferset which may be utilized with an ISO standard vial and stopper to transfer liquid from a conventional syringe to the vial or from a vial to a syringe after reconstituting a drug, for example, which is relatively simple in design and which reduces or eliminates contamination of the drug. It would also be desirable to eliminate the use of a conventional syringe needle to pierce the elastomeric stopper which seals the vial. As will be understood by those skilled in the art, a conventional syringe needle is thin and has an internal axial lumen or bore. The needle must therefore be withdrawn during aspiration of the vial or reaspiration where the medicament is reconstituted in the vial following delivery of a diluent or solvent to the vial. Where the needle is not substantially completely withdrawn during reaspiration of the vial, liquid medicament remains in the vial because the only liquid communication with the syringe is through the needle lumen. This may be a problem particularly where the vial is relatively small. For example, assuming a twenty millimeter long needle which pierces a two to three millimeter thick stopper, if the needle is pushed all the way through the stopper, there may be distance of as much as seventeen millimeters between the needle opening and the inner surface of the stopper. This amount below the needle lumen will not be reaspirated unless the needle is substantially withdrawn.
The vial transferset and method of this invention solves these problems by providing a relatively simple and efficient fluid transfer assembly which may be affixed to an ISO standard vial which assures complete reaspiration of the vial and which does not require accurate positioning of the needle during reaspiration.
The vial transferset or fluid transfer assembly of this invention is adapted to establish fluid communication between a syringe, intravenous (IV) device or the like and a sealed vial. As set forth above, the syringe and vial may be conventional and manufactured according to ISO standards. A conventional vial as presently used by the pharmaceutical companies includes an open end, a rim surrounding the open end and a reduced diameter neck portion adjacent the rim. The vial is sealed with a pierceable resilient stopper generally formed of an elastomeric material and most commonly includes a portion which is inserted into the neck of the vial and a planar rim portion which is received over the vial rim. The central portion of the planar rim portion which overlies the opening through the neck portion of the vial generally has a thickness of about two to three millimeters and the portion of the stopper which is received in the neck portion of the vial is generally tubular having an external diameter which is slightly greater than the internal diameter of the vial neck portion to assure a secure seal.
The transferset or transfer assembly of this invention includes a generally tubular transfer member having an open proximate end which is sealingly supported on the stopper rim portion for example in general coaxial alignment with the vial open end and an opened distal end adapted to receive a syringe or the like in sealed communication. As used in this application, the proximate end of a component such as the tubular transfer member is the end closest to the planar rim portion of the stopper and the distal end is the end furthest from the rim portion of the stopper. As will be understood, these terms are used solely to simplify the explanation of the invention and are not intended to define structure.
The transferset of this invention further includes a piercing member which is received within the tubular transfer member and reciprocally supported within the tubular transfer member by an internal surface of the tubular transfer member. The piercing member includes a relatively sharp preferably pointed piercing proximate end opposite the stopper rim portion adapted to pierce the stopper and an opposed distal end. As discussed more fully hereinbelow, the tubular transfer member provides fluid communication between the vial and a syringe, although the vial transferset of this invention may also be used to transfer fluid or liquid from a vial to another container, such as a second vial or an intravenous set. In the most preferred embodiment of the transferset of this invention, the piercing member includes at least one external generally longitudinal channel or groove rather than an internal lumen, thereby eliminating the problems associated with a conventional needle. Although the channel may take various forms and may include an internal channel, in the most preferred embodiment the channel is an external channel which extends generally longitudinally along at least a portion of the piercing member. As will be understood, the external channel in the piercing member extends generally longitudinally along the piercing member, but may extend spirally around the piercing member or include external and internal channels or multiple channels. Thus, when the piercing member is driven through the rim portion of the stopper, the external channel in the piercing member provides full fluid or liquid communication between the vial and the tubular transfer member. Of course, when the tubular transfer member is sealingly connected to a syringe, IV or the like, the tubular transfer member then provides fluid communication between the vial and the syringe. The preferred embodiment of the tubular transfer member then includes an annular or circular projecting sealing lip which is biased against the planar rim portion of the stopper assuring sealed communication between the vial and the tubular transfer member. In the most preferred embodiment, the sealing lip includes a relatively sharp edge which bites into the resilient stopper. As discussed more fully hereinbelow, the sealing lip of the tubular transfer member is preferably biased against the rim portion of the stopper sufficiently to stretch or prestress the rim portion of the stopper which overlies the vial opening.
The preferred embodiment of the transferset of this invention further includes a cup-shaped cap which encloses the assembly and maintains the sterility of the transferset assembly. The cup-shaped cap preferably includes a radial rim portion adjacent an open end of the cup-shaped cap which preferably sealingly engages the stopper rim portion, a tubular portion surrounding the tubular transfer member and a closed distal end enclosing the distal ends of the tubular transfer member and the piercing member. Although the cap may include a separate cover portion which is integral or separate from the remainder of the cap, in the most preferred embodiment, the cap is integrally formed, such that the distal end portion may be removed prior to use. In the disclosed embodiment, the tubular portion of the cap spaced from the rim portion includes a radial groove or grooves which weaken the tubular wall forming a frangible connection. The distal end of the cap portion may then be removed simply by twisting the distal end of the cap, thereby breaking the frangible connection.
The transfer assembly is secured to the vial by a generally tubular collar having a radially inwardly projecting portion or annular portion which is received over the cap radial rim portion, a tubular portion surrounding the cap radial rim portion and the vial rim and a distal radial rim portion which is received in the vial neck beneath the rim portion of the vial permanently securing the transfer assembly to the vial. In the most preferred embodiment of the transferset of this invention, the collar is formed of a malleable material such aluminum and the radial distal portion of the collar is then crimped into the neck portion of the vial beneath the vial rim portion. The collar of the transferset of this invention thus replaces the aluminum collar of a conventional vial and stopper assembly and easily accommodates the dimensional tolerances of the vial and stopper assembly. The vial is conventionally formed of glass or plastic.
As described above, the planar radial rim portion of the vial stopper is preferably stretched and prestressed over the open end of the vial during assembly of the transferset on the vial. The proximate end of the tubular transfer member includes a projecting sealing lip having a diameter less than the internal diameter of the vial open end. In one preferred embodiment, the sealing lip has a relatively sharp edge which may also bite into the resilient stopper. In the most preferred embodiment, the piercing member is reciprocally supported by an internal surface of the tubular transfer member, such that the piercing member can move toward the stopper to pierce the stopper, but the piercing member is prevented from moving away from the stopper and the relatively sharp piercing proximate end of the piercing member extends beyond the proximate end of the tubular transfer member. Upon assembly of the transferset on the vial, the piercing end of the piercing member then deforms and, in one disclosed embodiment, partially penetrates the planar rim portion of the stopper which is preferably stretched and prestressed over the vial opening by the sealing lip of the tubular transfer member, as described above. This combination may reduce the force required for the piercing member to fully pierce the planar rim portion of the stopper upon activation which is another advantage of the present invention. In another disclosed embodiment, the piercing end of the piercing member is slightly rounded and the external channel does not extend through the proximate end, such that the relatively sharp piercing end does not initially penetrate the rim portion of the stopper, but stretches the stopper as described. This embodiment strengthens the piercing end. Further, deforming the stopper planar rim portion and stretching the planar portion over the open end of the vial, reduces the volume of elastomeric material deformed into the V-shaped groove or external channel in the piercing member following piercing of the stopper, thereby improving fluid flow through the channel. In the disclosed embodiment, the tubular transfer member includes an internal diameter adjacent its distal end which is smaller than the internal diameter adjacent its proximate end and the piercing member includes a radial lip having a diameter greater than the smaller internal diameter of the tubular transfer member adjacent its distal end. Stated another way, the tubular transfer member has a larger counter bore adjacent its proximate end. The piercing member is thus free to move telescopically in the tubular transfer member toward the stopper, but prevented from moving away from the stopper. In the most preferred embodiment, the piercing member has a reduced diameter portion adjacent its proximate end and a pointed piercing end further reducing the force required to drive the piercing member through the planar rim portion of the stopper.
The most preferred embodiment of the transferset of this invention further includes a second seal surrounding the seal provided by the sealing lip of the tubular transfer member. In this preferred embodiment, the second seal is provided by an annular or circular lip which projects from the radial rim portion of the cap. In the most preferred embodiment, the radial rim portion of the cap includes at least one relatively sharp sealing lip which bites into the planar rim portion of the stopper providing an improved seal which maintains the sterile condition of the content of the transferset and prevents contamination.
As described above, the transferset of this invention may be affixed on a conventional vial and stopper assembly by the pharmaceutical companies under sterile conditions when the vial is filled and the transferset of this invention prevents contamination of the contents of the vial. The cap of the transferset seals the transfer assembly and the collar permanently secures the assembly on the vial, particularly where a malleable collar is utilized. The radially inwardly projecting or annular lip portion of the collar is preferably compressed against the radial rim portion of the cap as the distal end of the collar is crimped into the reduced diameter neck portion of the vial beneath the vial rim during assembly. This compression against the resilient planar rim portion of the stopper compresses the sealing lips of the cap and the tubular transfer member against the rim portion of the stopper, such that the sealing lips bite into the rim portion of the stopper assuring sealed communication between the stopper and the tubular transfer member. In the most preferred embodiment, the piercing end of the piercing member is also partially driven into the prestressed rim portion of the stopper overlying the open end of the vial, reducing the stroke required to drive the piercing member through the rim portion of the stopper as described above.
The method of assembling the improved transferset of this invention on a vial then includes inserting the elongated piercing member into the tubular transfer member, wherein the internal surface of the tubular transfer member telescopically supports the piercing member. Where the tubular transfer member includes an enlarged counterbore adjacent its proximate end and the piercing member includes a radial lip as described, the distal end of the piercing member is inserted through the proximate end of the tubular transfer member and the relatively sharp piercing end of the piercing member extends beyond the proximate end of the tubular transfer member. The method then includes inserting the distal end of the tubular transfer member into the open proximate end of the cup-shaped cap. In the most preferred embodiment of the transferset, the proximate end of the tubular transfer member includes a radial lip portion which is received within a counterbore of the radial rim portion of the cap, fixing the tubular transfer member in the cap, such that the projecting sealing lip of the tubular transfer member engages the planar rim of the stopper as described. Further, the piercing member is preferably releasably retained in the tubular transfer member, such that the components of the transferset and the collar may be preassembled and delivered in bulk to a pharmaceutical company, for example, for sterile assembly on vials. Finally, the assembled piercing member, tubular transfer member and cap are assembled on the vial and affixed by the collar. As described, the collar is most preferably formed of a malleable material such as aluminum and the radial rim portion of the collar is compressed against the rim portion of the cap as the distal end of the generally tubular cap is crimped into the reduced diameter neck portion of the vial beneath the vial rim. The compression of the radial rim portion of the collar against the rim portion of the cap compresses the resilient planar rim portion of the stopper, compressing the sealing lips into the rim portion of the stopper, stretching and prestressing the central portion of the planar rim portion of the stopper, assuring sealed communication between the vial and the tubular transfer member. In the most preferred embodiment, the method of this invention further includes driving the piercing end of the piercing member simultaneously into the planar radial rim of the stopper, deforming and may partially penetrate the stopper radial rim to reduce the stroke required to drive the piercing member through the stopper.
The method of transferring fluid or liquid medicament from the vial to a syringe or other container then includes first removing the cover portion of the cap to provide access to the tubular transfer member and the piercing member. In the most preferred embodiment, a radial groove is provided in the tubular portion of the cap spaced from the radial portion of the cap providing a frangible connection, such that the cover portion can be removed from the rim portion of the cap simply by twisting the distal end of the cap, breaking the frangible connection and permitting removal of the cover portion which includes the distal end of the tubular portion of the cap the closed end.
The transferset and vial assembly is now ready for use. As set forth above, the transferset of this invention may be utilized to transfer fluid from a vial to a syringe or IV set or any container; however, the disclosed embodiment of the transferset is specifically adapted to transfer liquid from a vial to a syringe or IV set or from a syringe or IV set to a vial. The distal end of the tubular transfer member includes a connector adapted to connect the tubular transfer member to a syringe to establish fluid communication between the tubular transfer member and the interior of a syringe, such as a Luer lock or Luer connector. A conventional syringe includes a tubular portion, a plunger having a head or fluid piston reciprocally mounted in sealed relation within the tubular portion and a reduced diameter tubular nozzle portion opposite the plunger head. The inside diameter of the tubular transfer member of the transferset is preferably greater than the outside diameter of the tubular nozzle portion of the syringe and the outside diameter of the syringe nozzle portion is generally approximately equal to the diameter of the distal end of the piercing member. Thus, the syringe nozzle portion may be telescopically received within the distal end of the tubular transfer member, wherein it is driven against the distal end of the piercing member. The reduced diameter nozzle portion is generally recessed within the tubular portion of the syringe, such that the proximate end of the syringe tubular portion surrounds the nozzle portion forming a tubular collar. The proximate end of the tubular collar includes a connector, such as a female Luer lock. In the disclosed embodiment, the distal end of the tubular transfer member includes a male Luer lock connector adapted to mate with the female Luer lock of the syringe.
Following removal of the cover portion of the cap as described above, the connector on the syringe is connected to the connector on the distal end of the tubular transfer member which drives the reduced diameter nozzle portion of the syringe into the distal open end of the tubular transfer member and the free end of the syringe nozzle portion is then driven against the distal end of the piercing member, driving the piercing end of the piercing member through the planar rim portion of the stopper. In summary, the method includes connecting the syringe to the distal end of the tubular transfer member, establishing fluid communication between the syringe through the nozzle portion and driving the piercing end of the piercing member through the rim portion of the stopper. Fluid communication is thus established between the inside of the vial and the syringe through the tubular transfer member.
In the most preferred embodiment of the transferset of this invention, wherein the piercing member includes an external generally longitudinal channel, this communication is established through the external generally longitudinal channel in the piercing member. In the most preferred embodiment, the channel in the piercing member extends from adjacent the piercing end to at least the enlarged portion of the piercing member and most preferably through at least an extended portion of the length of the piercing member. The connector on the syringe is most preferably a threaded connection, such as a Luer lock. In one embodiment, this threaded connection has several turns whereby the proximate end of the piercing member is driven completely through the planar rim portion of the stopper by threading the threaded connection of the syringe on the distal end of the tubular transfer member. In another embodiment, the proximate end of the piercing member is driven through the stopper by fluid pressure from the syringe.
As will now be understood, the piercing member in the transferset of this invention has several important advantages over the prior art. First, the piercing member is easy to manufacture. The longitudinal channel may be a V-shaped channel for example which extends the entire length of the piercing member. Such a channel is easier to manufacture than a needle having very small lumen as presently used. More importantly, in the transferset of this invention, a piercing member having an external channel assures complete aspiration or reaspiration of the vial without requiring partial withdrawal of the needle which exposes the healthcare worker to being pricked by the needle (if inadvertently fully withdrawn) and contamination of the liquid medicament. The external channel provides full communication of the liquid content of the vial, whereas a needle with a lumen requires substantial withdrawal of the needle from the vial to provide full communication through the stopper as described above. Fluid communication between the syringe and the vial is then provided by the tubular transfer member rather than the needle in the transferset of this invention. Thus, the described piercing member provides several important advantages in the transferset of this invention over the prior art.
As described, the transferset of this invention may be utilized to reconstitute dry or powdered drugs into liquid form with an appropriate diluent or solvent solution prior to administration to a patient. For example, the syringe may contain a solvent solution or diluent which is injected into the vial through the tubular transfer member and the external channel of the piercing member by depressing the plunger head of the syringe. The reconstituted drug or medicament may then be reaspirated from the vial to the same syringe by withdrawing the plunger head for administration to a patient. The healthcare worker is never exposed to a needle during this operation and the piercing member remains with the transferset and vial assembly because it is never connected to the syringe. The tubular transfer member is then removed from the syringe and replaced with a needle for application of the liquid medicament to a patient or connected directly to an IV line.
As will be understood, the terms tubular and tubular portion are used herein to connote a generally tubular shape. Although the disclosed embodiments are generally cylindrical tubes which are more convenient to manufacture, the tubular portions may be of any convenient shape, including polygonal. Other advantages and meritorious features of the present invention will be more fully understood from the following description of the preferred embodiments, the claims and the appended drawings, a brief description of which follows.